VCC combination in relapsed or refractory AML

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, prospective, single-arm Phase 2 study. It tests the efficacy and safety of the VCC combination in adults with relapsed or refractory AML. Participants receive the VCC regimen per a predefined protocol, with the primary goal of measuring antileukemic activity and secondary goals including safety and tolerability. The study will monitor response rates, survival outcomes, and adverse events to determine whether the treatment warrants further investigation. Enrollment is limited to eligible adults under specific organ-function and performance-status criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Histologically confirmed acute myeloid leukemia (AML) with relapsed or refractory disease, including:

   * Refractory AML, defined as failure to achieve remission after at least one prior treatment;
   * Relapsed AML, defined as ≥5% blasts in the bone marrow after a previous remission;
   * AML arising from myelodysplastic syndrome (including CMML) or myeloproliferative neoplasms (secondary AML or therapy-related AML \[t-AML\]) is also eligible.
2. Age ≥18 years, regardless of sex, with an expected survival of \>3 months.
3. Estimated creatinine clearance ≥50 mL/min.
4. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 × the upper limit of normal (ULN), unless the abnormality is considered attributable to leukemic organ involvement; total bilirubin ≤3.0 × ULN, unless the abnormality is considered attributable to leukemic organ involvement.
5. Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
6. Participants must not be pregnant and must agree to use effective contraception during study treatment.
7. Ability to understand the study and willingness to provide written informed consent.

Exclusion Criteria:

1. Acute promyelocytic leukemia (APL).
2. Active central nervous system leukemia.
3. Clinically significant cardiovascular disease, including any of the following:

   * Clinically significant QTc prolongation (QTc \>450 ms in males or \>470 ms in females);
   * Ventricular tachycardia;
   * Second-degree atrioventricular block;
   * Myocardial infarction within 1 year prior to enrollment;
   * Congestive heart failure;
   * Coronary artery disease requiring medical treatment.
4. Active, uncontrolled severe infection.
5. Other non-hematologic malignancies within the previous 2 years.
6. Psychiatric disorders that may interfere with participation in the study.
7. Previous solid organ transplantation. Prior stem cell transplantation (SCT) is permitted; however, patients with graft-versus-host disease (GVHD) or those receiving ongoing immunosuppressive or GVHD-directed therapy are not eligible.
8. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in the study.

Where it's running

• the First affiliated hospital of xiamen university
  Xiamen, Fujian, China Recruiting

Study contacts

• Principal investigator: Bing Xu — The First Affiliated Hospital of Xiamen University
• Study coordinator: Bing Xu, PhD
• Email: xubingzhangjian@126.com
• Phone: 18750918842

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.